1. Technical Field
This invention relates generally to surgical drapes, and more particularly to surgical drapes used to cover radiological imaging equipment to maintain sterility in a surgical theatre.
2. Related Art
The need to provide a sterile environment in a surgical theatre is directly associated with the known risk of infection that can be caused by bacteria, such as from a person or surgical equipment, in the surgical theatre. As such, it is known that in order to minimize the risk of infection during a surgical procedure, it is necessary to prevent the transfer of bacteria, such as via airborne lint or dust particles, fluids, or otherwise, within the surgical theatre. Although the risks of infection caused during surgery are known, it remains a challenge to prevent their onset. Infections are estimated to affect about 2 million patients annually and result, directly or indirectly, in an estimated 100,000 deaths. Aside from the loss of life, the infections create an economic burden on hospitals. For example, some studies estimate that each bloodstream infection in a patient results in an average cost of $26,839 to the hospital. As such, to date, about 16 states have passed laws detailing how hospitals treat patients in an effort to decrease the associated risks of infection to the patients.
Surgical site infection has been estimated to occur in about 15% of clean surgeries and about 30% of contaminated surgeries. Using plastic drapes to protect the wound from organisms that may be present on the surrounding skin during surgery is one strategy used to inhibit surgical site infection. However, the current draping technique uses what is referred to as a “half sheet”, which is a plain rectangular sheet of plastic material that is draped over the patient and hangs downwardly over the sides edges of an operating table. In standard operations not requiring relatively large, specialized surgical equipment, this half sheet type of drape can prove effective. However, in some cases it is necessary to introduce relatively large, unsterilized surgical equipment in the operating room (surgical theater) for use during a surgical procedure. For example, in spinal and orthopedic surgeries it is common to take radiological images of various parts of the patient's body as the surgery is being performed. The most common piece of radiological imaging equipment is a C-arm fluoroscopy unit. A C-arm obtains its name from a relatively large, generally C-shaped arm that allows the imaging portion of the unit to be swung into multiple positions desired during surgery, while the arm extends beneath and through opposite sides of the operating table. As a result, the unit has one unsterilized portion adjacent one side of the patient and another unsterilized portion adjacent an opposite side of the patient.
Given the large, arcuate shape of the C-arm fluoroscopy unit, and its mobility during use, it becomes ever so challenging to maintain sterility of the surgical theatre. Typically, though cumbersome, multiple half sheets are disposed about the unit during its use. This often results in delays of the surgical procedure and requires creativity on the part of the surgical staff in order to best deploy the sheets about portions of the unit, particularly the arm and an imaging end of the unit. The need for creativity results from the fact that there is no single accepted methodology for draping C-arm radiological units. Of course, if the half sheets are not properly deployed, then the sterility of the surgical theater is compromised, and thus, the potential for onset of infection in the patient increases. Finally, because this type of radiological equipment is moved repeatedly during surgery, even if the unit is initially draped properly, there remains an associated risk that the current draping mechanisms will become displaced, thereby exposing unsterilized portions of the unit. Accordingly, a need exists for an improved sterile drapes and method of establishing and maintaining sterility in a surgical theatre, particularly for use with relatively large, radiological imaging equipment, e.g., C-arm radiological units.